SI-BONE expects packaging-related recall work to affect approximately 3,900 implants and to generate an aggregate gross charge of up to approximately $150,000. Investors are told third-quarter Revenue is not otherwise expected to be affected, while the company says additional inventory should support implant Supply and physician treatment.

Key Highlights

  • The company extended its Santa Clara headquarters Lease for a month at $43,696 in monthly base rent.
  • A packaging failure prompted quarantine, repackaging and re-sterilization work involving affected iFuse TORQ inventory.
  • SI-BONE recalled iFuse TORQ implants after tube packaging from specific lots failed sterile-barrier acceptance criteria, creating a potential infection risk.
  • The company said third-quarter revenue is not otherwise expected to be affected, while additional on-hand inventory should support implant availability.

The company says third-quarter revenue is not otherwise expected to be affected, while additional on-hand inventory should support implant availability for physicians and patient treatment.

iFuse TORQ Packaging Issue Drives Recall Costs

The recall began after tube packaging from specific lots failed acceptance criteria for maintaining a sterile barrier, creating a potential infection risk. SI-BONE (NASDAQ: SIBN) said the affected inventory includes implants distributed to its field salesforce and customers, alongside units held in its Warehouse or managed by its implant manufacturer. The company and its Manufacturing partners are investigating the issue with the FDA. Costs include recalling and sorting warehouse inventory, then repackaging and re-sterilizing affected implants.

Santa Clara Lease Extended at $43,696 Monthly

SI-BONE also extended the lease covering approximately 21,848 square feet at its Santa Clara headquarters for a month. Base rent during that period is $43,696 per month, calculated at $2.00 per rentable square foot, while the company continues paying its share of operating expenses and taxes. The lease’s security deposit is $199,570.56. SI-BONE plans to seek recovery from the tube manufacturer, although the company said recovery is not assured. It expects to provide any further potential financial-impact details when reporting third-quarter results.